McCole is a highly experienced professional with a 20 year IT implementation track record. His experience includes 15 years of developing and supporting Quality Management System programs and 10 years of managing Enterprise Resource Planning system programs. He also has experience with business process improvement, regulatory compliance and the governance supporting technologies in the life sciences industry. Most recently, McCole was a Director of Quality/CAPA Systems and Compliance where he created a global quality system for one of the largest bio-pharmaceutical manufacturers in the world.

McCole will use his extensive experience in Quality Management Systems to assist USDM Life Sciences clients with enhancing their QMS, achieving their quality objectives and maintaining regulatory compliance. McCole has experience with many QMS and ERP vendors, including ETQ, Master Control, Oracle, Pilgrim, SAP and TrackWise.

"I look forward to working together with our clients to stimulate continuous quality management improvements and business benefits through the deployment of operational excellence," said McCole.

"Brian is a welcome addition to lead the Enterprise Quality Management Practice. His thought leadership, hands-on knowledge and experience with QMS systems and regulations augments our existing staff and provides an unparalleled blend of expertise to USDM's capabilities," said Robert Lesnefsky, Global Vice President of Quality Assurance and Regulatory Compliance and Auditing at USDM Life Sciences.

McCole is consistently recognized by client management as an excellent resource to improve organizational effectiveness, remediate noncompliance, and provide clear, logical and defensible compliance positions. He has a keen focus on new approaches that are both compliant and end-user focused.

About USDM Life Sciences:USDM Life Sciences is a leading global regulatory consulting firm providing compliance, validation, qualification, quality, auditing and information technology services via project teams and staff augmentation to our clients in the medical device, biotechnology, biologics, diagnostics and pharmaceutical industries. USDM Life Sciences has more than 13 years of experience supplying our clients in the life science industry with compliance services during each phase of their drug and product development cycle while partnering with best of breed organizations to help companies simplify, unify and optimize their business and compliance objectives. For more information, please visit www.usdm.com.